His-Bundle Corrective Pacing in Heart Failure
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with heart failure and right bundle branch block (RBBB).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age 18 years or older (no upper age limit)
• Optimal medical therapy for heart failure by current guidelines
• Class IIa or IIb guideline-based indication for CRT-D implant in RBBB patients, including one of the following:
‣ New York Heart Association (NYHA) class II HF symptoms, LVEF ≤ 30% and QRS≥ 150 ms (IIb); OR
⁃ NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration ≥ 150 ms (IIa); OR
⁃ NYHA class III-IV a HF, LVEF ≤ 35%, and QRS duration 120-149 ms (IIb)
Locations
United States
Arizona
University of Arizona
RECRUITING
Phoenix
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Florida
University of South Florida
RECRUITING
Tampa
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Rush University Medical Center
RECRUITING
Chicago
University of Chicago
RECRUITING
Chicago
North Carolina
Mission Health
RECRUITING
Asheville
New Jersey
Valley Health System
RECRUITING
Ridgewood
New York
Mount Sinai Hospital
RECRUITING
New York
Weill Cornell Medical College
RECRUITING
New York
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Geisinger Wyoming Valley
RECRUITING
Wilkes-barre
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Vermont
University of Vermont
RECRUITING
Burlington
Contact Information
Primary
Ann Colasurdo
ann.colasurdo@heart.rochester.edu
585-275-1054
Backup
Mary Brown
mary.brown@heart.rochester.edu
585-273-5283
Time Frame
Start Date: 2022-12-02
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 120
Treatments
Active_comparator: His-CRT implantation
His-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an endocardial His-bundle pacing leads directly pacing the intrinsic conduction system.
Active_comparator: BIV-CRT implantation
BIV-CRT implantation includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus.
Related Therapeutic Areas
Sponsors
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of Rochester